Skip to main content
Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
    • Policies
    • Fellowship
    • Careers
  • Projects
    • Column 1
      • Advancing Regulatory Science
        • Oncology Multi-Regional Clinical Trials
        • Rare Disease Innovation Roundtable
      • Animal Health & Veterinary Medicine
        • Antimicrobial Use in Food Animals
        • Cross-Sectoral Health Threats
        • Industry SWOT Analysis
      • Expanded Access
        • E-request App
        • Navigator
        • Resources for COVID-19
      • FDA Patient Listening Sessions
    • Column 2
      • Food & Nutrition
        • About
        • Food Traceability
        • Healthy Rule Roundtables
        • Nutrition Facts Label
        • Produce Safety Stakeholder Dialogue
        • Retail Dietitian Toolkit
      • Improving Access to FDA Information
        • Understanding FDA & FDA-Regulated Products
        • Improving Access to Publicly Available FDA Information
      • Research
        • About
        • IMEDS
          • IMEDS Inquiry
        • Post Market Research
        • RAISE
        • Real World Data
        • Regulatory Science Accelerator
    • Substance Use Disorders
  • News and Events
    • Innovations in Regulatory Science & Policy Awards
    • Events
    • News
    • Publications
    • 2026 Annual Public Meeting
  • Expanded Access eRequest
  • facebook
  • twitter
  • linkedin
  • youtube
Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Advancing Regulatory Science
          1. Oncology Multi-Regional Clinical Trials
          2. Rare Disease Innovation Roundtable
        2. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Cross-Sectoral Health Threats
          3. Industry SWOT Analysis
        3. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        4. FDA Patient Listening Sessions
      2. Column 2
        1. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
        2. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        3. Research
          1. About
          2. IMEDS
          3. Post Market Research
          4. RAISE
          5. Real World Data
          6. Regulatory Science Accelerator
      3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. Events
      3. News
      4. Publications
      5. 2026 Annual Public Meeting
  • Expanded Access eRequest
  1. Home

Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.

The information provided here is drawn from ClinicalTrials.gov.

Emergency INDs

To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.

Search Tips

To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.

Displaying 10 of 29

Neuroganics LLC

COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

Conditions: Communicable Disease, COVID-19, SARS-COV2, Infectious Disease, Coronavirus, Virus

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g.immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigentests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and ArtronLaboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracycompared to Centers for Disease Control (CDC)-recommended molecular genetic testing andclinical diagnosis. Second, it is our goal to determine if self-testing assisted byCOVIDscanDX mobile device camera acquisition software platform and telemedicineclinical/technical support (virtual point-of-care) improves the ease of use and immediateinterpretation of the tests, thus making self-testing comparable in accuracy and safetyto testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 afterdiagnosis with COVID-19 or following vaccination to measure the onset and time course ofdetectable antibodies from finger-stick blood drops and rapid antibody lateral flowtests. The overall purpose of the study is to dramatically increase the capacity ofCOVID-19 testing by establishing the safety, ease-of-use and validity of self-testingassisted by mobile device imaging and telemedicine remote support and provide evidence ofantibody time-course response to vaccination.

University of Catanzaro

Biomarkers for Identification of COVID-19 Infection

Conditions: Coronavirus

Acute lung injury represents the most severe form of the viral infection sustained bycoronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged inDecember 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-likesyndrome with fever and cough; patients with clinical symptoms can perform a swab test,including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even ifdiagnosis and treatment are well described, to date, this viral pandemic infectioninduces an increased mortality in the world. The aim of the present project is toevaluate specific biomarkers that could be used for patient stratification and for tailortherapy in COVID-19 infected patients.

University of Zurich

Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches

Conditions: Corona Virus Infection, ARDS, Coinfection

In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global populationand health care systems are facing unprecedented challenges through the combination oftransmission and the potential for severe disease. Acute respiratory distress syndrome(ARDS) has been found with unusual clinical features dominated by substantial alveolarfluid load. It is unknown whether this is primarily caused by endothelial dysfunctionleading to capillary leakage or direct virus induced damage. This knowledge gap issignificant because the initial balance between fluid management and circulatory supportappear to be decisive. On progression of the disease, bacterial superinfectionfacilitated by inflammation and virus related damage, has been identified as the mainfactor for patient outcome, but the role of the host versus the environment microbiomeremains unclear.The overarching aim of the present research proposal is to improve therapeutic strategiesin critically ill patients with ARDS due to SARS-CoV-2 infection by advancing thepathophysiological understanding of this novel disease. This research thus focuses oninflammation, microcirculatory dysfunction and superinfection, aiming to elucidate riskfactors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients andcontribute to the rationale for therapeutic strategies. The hypotheses are that (I) theprimary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggeratedpro-inflammatory response causing primary endothelial dysfunction, and subsequentlyacting two-fold on the degradation of the lung parenchyma - through the primary cytokineresponse, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophilaxis. The pronounced inflammation and primary damage to the lung disrupts the pulmonarymicrobiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterialsuperinfections are a significant cause of morbidity and mortality in COVID-19 patients.Pathogen colonization main Risk Factor for lower respiratory tract infections. Toestablish colonization, pathogens have to interact with the local microbiota (a.k.a.microbiome) and certain microbiome profiles will be more resistant to pathogen invasion.Finally, (III) Handheld devices used in clinical routine are a potential reservoir andcarrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.

King's College London

Testing the Accuracy of a Digital Test to Diagnose Covid-19

Conditions: COVID-19

The Covid-19 viral pandemic has caused significant global losses and disruption to allaspects of society. One of the major difficulties in controlling the spread of thiscoronavirus has been the delayed and mild (or lack of) presentation of symptoms ininfected individuals, and the insufficient Covid-19 testing capacity in the UK. Thiswarrants the development of alternative diagnostic tools that reliably assess Covid-19infection in the early stages of infection, while also being low- cost, low-burden, andeasily administered to a wide proportion of the population.This study aims to validate machine learning models as a diagnostic tool that predictsinfection with SARS-CoV-2 based on app-reported symptoms and phenotypic data, against the'gold-standard' swab PCR-test. This study will take place within the Covid Symptom Studyapp, the free symptom tracking mobile application launched in March 2020.

Versailles Hospital

RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

Conditions: SARS-CoV Infection, Pinkeye

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctivaof covid-19 patients and the presence or absence of conjunctivitis in these patients

Oslo University Hospital

Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19

Conditions: SARS Virus, Severe Acute Respiratory Syndrome

Oslo University Hospital has initiated an observational study on hospitalised patientswith confirmed COVID-19, the infection caused by Severe Acute Respiratory SyndromeCoronavirus type 2 (SARS-CoV-2).

Institut National de la Santé Et de la Recherche Médicale, France

Immunity and Infections in the Psychiatric Population

Conditions: COVID, Psychiatric Disorders

The main objective of this multicenter cohort study is to determine the degree of COVID19infection immunization of a population of psychiatric patients.The secondary objective of this cohort follow-up is to: 1. Clinically characterize COVID patients who are positive for serological testing 2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis 3. Immunologically characterize COVID patients who are positive for serological testing 4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Bernhoven Hospital

Influence of COVID-19 on Vascular Endothelial Function

Conditions: COVID, Vascular; Damage

Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2could result in endothelial dysfunction with increased risk of arterial thrombotic eventsby downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelialfunction can be easily and non-invasively determined by carotid artery reactivity (CAR)testing.Objective: To investigate the predictive value of endothelial dysfunction, measured bycarotid artery reactivity testing, for 1-year cardiovascular events in patients with pastCOVID-19 infection.Study design: A prospective observational longitudinal cohort study.Study population: Patients recovered from confirmed infection with SARS-CoV2.Main study parameters/endpoints: macrovascular endothelial function measured by carotidartery reactivity testing.

Children's Hospital Medical Center, Cincinnati

Repeated Employee Testing for Understanding Our Recovery to Normal

Conditions: COVID-19

The purpose of this research study is 1) to conduct a prospective longitudinalsurveillance research trial, enrolling up to 200 CCHMC employees as they come back towork, and then following their clinical and laboratory parameters for up to 12 months;and 2) to support the ongoing development of diagnostic techniques for COVID-19. Theoverall goal is to investigate patterns of SARS-COV-2 infection, including immunologicalrecovery and genetic risk factors, among CCHMC employees to better understand how tosafely reintroduce the CCHMC work force back into their normal routines.

TMC HealthCare

Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients

Conditions: COVID-19, SARS-CoV-2 Infection

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negativelyimpacted global health and requires more research to develop better tests and to improvedisease treatment.The purpose of this research is to aid in the testing effort by collecting samples frompeople who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samplesyou provide will be used investigationally by INanoBio to develop a test to determinewhen antibodies against various SARS-CoV-2 proteins are detectable.Up to approximately 80 subjects of all ages with either a suspected or lab-confirmeddiagnosis of COVID-19 will take part in this research.

Pagination

  • Current page 1
  • Page 2
  • Page 3
  • Next page ››
  • Last page Last »

Status

  • (-) Unknown status (29)

Intervention Type

  • (-) Diagnostic Test (29)
  • Other (2)
  • Biological (1)

Subscribe for updates from the Reagan-Udall Foundation for the FDA

Subscribe
(202) 849 - 2075
1333 New Hampshire Ave, NW
Suite 420
Washington, DC 20036
admin@reaganudall.org
  • facebook
  • twitter
  • linkedin
  • youtube

© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA